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Completed

NCT Number: NCT00301327

Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.)for the Treatment of Head Lice.

This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.

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Key information

Conditions

Head Lice

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Global Health Associates of Miami 7800, SW 57 Avenue, Suite 219E, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females 6 months of age or older.
  • Have an active infestation with pediculus capitis, the human head louse, with at least three live lice at baseline.
  • Agree not to use any other pediculicides or medicated hair-grooming products during the duration of the study.
  • Be healthy, non-febrile, and not suffering from an infection likely to require antibiotic therapy during the study period.
  • Subject or guardian is able to understand the new HIPAA regulations and sign the HIPAA form.
  • Subject or guardian has read, understood, and signed appropriate informed consent in English. If English is not the primary language, the information about the study must be explained in their language and a copy of the informed consent must be in that language.
  • Subject is willing to participate in the study, and abide by the protocol requirements.

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Exclusion criteria

  • Participation in any clinical study within the past 30 days.
  • Known hypersensitivity to any ingredient in the product formulation.

Treatment and study plan

Summers 5% L.A.

Drug

Primary outcomes

  1. Treatment success is defined as the absence of live lice.

Secondary outcomes

  1. The cumulative proportions of subjects determined to be treatment failures at the Second Evaluation Visit.

Sponsors and collaborators

Lead sponsor

Summers Laboratories

Industry

Registry information

Official study title

A Multi-Center, Randomized, Vehicle Controlled, Double Blind Clinical Trial to Evaluate the Efficacy and Safety of Summers Non-Pesticide Lice Asphyxiator (L.A.) for the Treatment of Head Lice.

Important dates

Study start
2006
First posted
Mar 10, 2006
Registry last updated
May 30, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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